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Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00355953
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : April 22, 2008
Information provided by:
University of Messina

Brief Summary:
The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.

Condition or disease Intervention/treatment Phase
Menopause Osteopenia Drug: Genistein Phase 2 Phase 3

Detailed Description:

Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. On the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression.

Particularly, and in extreme synthesis the following parameters have been studied during the treatment:

  1. inflammation markers as fibrinogen
  2. lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-
  3. endothelial function markers as VCAM-1 and ICAM-1
  4. oxidative stress by the evaluation of the F(2)-isoprostane
  5. cytokines as IL-6, OPG, RANK and RANKL
  6. bone mineral density, by DEXA, at lumbar spine and femoral neck
  7. Bone turnover markers as B-ALP, PYR, D-PYR
  8. PAP-test, transvaginal uterine ecography and mammography.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2003
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Genistein

Primary Outcome Measures :
  1. Efficacy:
  2. bone resorption/formation
  3. bone mineral density
  4. cardiovascular risk factors
  5. Safety:
  6. endometrial thickness

Secondary Outcome Measures :
  1. Efficacy:
  2. hot flushes reduction
  3. Safety:
  4. mammography
  5. vaginal cells maturation value

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least one year of menopause
  • No use of hormone replacement therapy
  • Bone mineral density T-score at the femoral neck minor than one S.D.

Exclusion Criteria:

  • Concomitant disease
  • Smoke habit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355953

Sponsors and Collaborators
University of Messina
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Study Director: Francesco Squadrito, MD University of Messina
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00355953    
Other Study ID Numbers: 2002067398
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008
Keywords provided by University of Messina:
Post-Menopausal Women
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists